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Regulatory Leadership

Trusted Regulatory Expertise

Engage Bioclinica early in your drug development program to leverage an exceptional level of regulatory, scientific and operational expertise. For more than 30 years, Bioclinica has accelerated drug development research, working in tandem with regulatory bodies and key clinical research associations to establish core lab industry standards.

Bioclinica's unmatched scientific and regulatory leadership is well recognized and backed by ongoing professional relationships with key authorities and panels. We have an unprecedented number of successful, medical image data submissions on many high-profile drugs on the market today.

30
Years of Experience
70
Countries
190
FDA approvals

Leverage Bioclinica's Expertise

Contact us for more information or to speak with us about how we can support your next trial.

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Streamlined Regulatory Process

Our experts have a deep understanding of imaging review charter and protocol development, adhering to guidance and directives from the FDA, EMA, and other regulatory agencies. Bioclinica senior team members participate in FDA meetings and workshops, taking an active leadership role in shaping new guidance surrounding imaging endpoints in clinical trials. Our significant experience in charter and protocol development means effective trial conduct and preparedness for regulatory review. Bioclinica ensures complete image data archival and all processes are in full compliance with 21 CFR Part 11.

Therapeutic Strength

Bioclinica offers extensive international experience including working in tandem with a wide array of organizations, across most major indications, in more than 70 countries. Working alongside global regulatory authorities, Bioclinica lead the advancement of Thorough QT (TQT) and Intensive QT trial design, highlighted by the completion of the first-ever TQT studies in China and Japan.

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Oncology Superiority

Bioclinica is proud to have contributed to 70+ FDA approvals for treating a wide variety of oncology indications. Our extensive medical experience, coupled with our commitment to quality, enables us to support every type of oncology trial.

Cardio-Oncology

The association of many oncology drugs with cardiotoxic side effects necessitates independent cardiac safety studies for therapies in development. Bioclinica has extensive expertise in planning and implementing cardiac safety studies (ICH-E14 mandated Thorough QT services, blood pressure analysis, etc), facilitating the assessment of drugs early in clinical development.

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Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

ICYMI: Take a look at Bioclinica Clinical Adjudication that caught the judges' eye in the recent Scrip Awards. It's… https://t.co/gPk4aLmTuA
Bioclinica (2 weeks ago)
Still time to catch up with Aina Lihn, Kathleen Kane, Anette Vierning and other Bioclinica folks at #PCTRIALS https://t.co/E3qxdjqTV5
Bioclinica (2 weeks ago)
Awesome day 2 at #PCTRIALS in Barcelona! Great to connect w new & long-time partners & #lifescience clients! https://t.co/ElM3VPCoSk
Bioclinica (2 weeks ago)
Great talk by @bioclinica's CIO & EVP Technology Gavin Nichol at #PCTRIALS 2018 on #FDA recent guidance on EHR EDC… https://t.co/geIjGIFL06
Bioclinica (2 weeks ago)
Great talk by @bioclinica's CIO & EVP Technology Gavin Nichols at #PCTRIALS 2018 on #FDA recent guidance on EHR EDC… https://t.co/agqP32q09W
Bioclinica (2 weeks ago)
Ask us about technology-enabled clinical development powered by science! Hear our CIO in a day 2 talk. See… https://t.co/iZyF8ixV79
Bioclinica (3 weeks ago)

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